Priory Analysts' uses a ‘5x5' matrix in approaching regulatory affairs.

‘5x5' means Five Rules and Five Steps:

Five Rules:
Rule 1: In the medical device business regulatory is king - but must not be dictator
Rule 2: Regulatory requirements must be considered from design concept to disposal
Rule 3: Define the trading blocks or markets
Rule 4: Record everything
Rule 5: The source of good regulatory is good, ethical science. However not all good science is good regulatory

Five Steps:
Step 1: Define the product - what does it do? Is it a medical device?
Step 2: Apply the law
Step 3: Plan the data requirements
Step 4: Write everything down clearly, concisely and well structured
Step 5: Undergo assessment by an external regulatory authority